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Total 41 results found since Jan 2013.
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
RARITAN, NJ, May 25, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical...
Source: Johnson and Johnson - May 25, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
ERLEADA ® (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option, Now Available in the U.S.
HORSHAM, Pa., April 3, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the availability of an additional tablet strength of ERLEADA® (apalutamide) in the United States. The introduction of the 240mg tablet provides the first-and-only option for a once-daily, single-tablet Androgen Receptor Inhibitor (ARI) approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).With two strengths available, healthcare professionals will have the flexibility to...
Source: Johnson and Johnson - April 3, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
New VOYAGER PAD Analysis Confirms Consistent Benefit of XARELTO ® (rivaroxaban) Plus Aspirin Following Lower Extremity Revascularization (LER)
TITUSVILLE, NJ, March 5, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD. Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of ...
Source: Johnson and Johnson - March 5, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Data at ASCO GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention
RARITAN, N.J., February 13, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced plans to present more than 20 abstracts featuring seven oncology therapies from its robust portfolio and pipeline at the annual American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place in San Francisco on February 16-18. Building on more than a decade of leadership in the development of medicines for people diagnosed with GU cancers, Janssen will present data demonstrating its ambition to advance patient-centered treatment through precision medicine, real-world evidence a...
Source: Johnson and Johnson - February 13, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Pfizer Covid-19 Bivalent Vaccine And Stroke Risk: What You Need To Know
There ’s been a lot of chatter about the January 13 announcement from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) about a possible “safety signal” for the Pfizer-BioNTech Covid-19 bivalent booster vaccine.
Source: Forbes.com Healthcare News - January 14, 2023 Category: Pharmaceuticals Authors: Bruce Y. Lee, Senior Contributor Tags: Healthcare /healthcare Innovation /innovation Science /science business pharma Source Type: news
Real-World Study Confirms Benefit of XARELTO ® (rivaroxaban) for Secondary Prevention of Venous Thromboembolism in Cancer Patients
TITUSVILLE, NJ, December 9, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced observational data from eight years of clinical practice showing that the oral Factor Xa inhibitor XARELTO® (rivaroxaban) is associated with comparable effectiveness and safety to the Factor Xa inhibitor apixaban for the treatment of cancer-associated thromboembolism (CAT) in a broad cohort of patients with various cancer types. Patients with CAT are at a higher risk of venous thromboembolism (VTE), which is the second-leading cause of death in people with cancer.1Data from the Observational Study in Cancer-A...
Source: Johnson and Johnson - December 9, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Late-Breaking Data from Pivotal Phase 3 PRECISION Study Demonstrates Significant and Sustained Effect of Aprocitentan on Lowering Blood Pressure for Patients with Difficult-to-Control Hypertension
RARITAN, NJ, November 7, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with Idorsia Ltd, today announced results from the Phase 3 PRECISION study, which found aprocitentan, an investigational, novel dual endothelin receptor antagonist (ERA), significantly reduced blood pressure (BP) and maintained the effect for up to 48 weeks when added to standardized combination background antihypertensive therapy in patients with difficult-to-control hypertension (sometimes referred to as resistant hypertension). These data were presented as a Late-Breaking Science presentation during the Amer...
Source: Johnson and Johnson - November 7, 2022 Category: Pharmaceuticals Source Type: news
Janssen ’s Save Legs. Change Lives.™ is Creating a More Equitable Future for Communities at Risk of PAD-Related Amputations
TITUSVILLE, NJ, November 4, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the first impact summary for its Save Legs. Change Lives.™ Spot Peripheral Artery Disease Now multi-year initiative, designed to create urgency and action around the hidden threat of peripheral artery disease (PAD)-related amputation. In its inaugural year, Save Legs. Change Lives.™ focused on reaching Black Americans, who are up to four times more likely than white Americans to have a PAD-related amputation.1 With this critical initiative, Janssen is focused on helping those at risk of PAD through more th...
Source: Johnson and Johnson - November 4, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
U.S. FDA Approves TECVAYLI ™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., October 25, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved TECVAYLI™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.1 TECVAYLI™ is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment.1 This off-the-shelf (or ready to use) therapy uses innovative science to ac...
Source: Johnson and Johnson - October 25, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Flu Vaccine Offers Moderate Protection From Stroke
WEDNESDAY, Sept. 7, 2022 -- Influenza vaccination seems to have a moderate protective effect on ischemic stroke, according to a study published online Sept. 7 in Neurology.
Sara Rodríguez-Martín, Pharm.D., Ph.D., from the University...
Source: Drugs.com - Pharma News - September 7, 2022 Category: Pharmaceuticals Source Type: news
Vaccination Cuts Risk for Myocardial Infarction, Stroke After COVID-19
FRIDAY, July 29, 2022 -- Full vaccination against COVID-19 is associated with a lower risk for acute myocardial infarction (AMI) and ischemic stroke 31 to 120 days after COVID-19, according to a research letter published online July 22 in the...
Source: Drugs.com - Pharma News - July 29, 2022 Category: Pharmaceuticals Source Type: news
New Data From Two Large Studies Reinforce Effectiveness of Dual Pathway Inhibition (DPI) with XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD)
RARITAN, N.J., May 23, 2022 – Findings from the XARELTO® (rivaroxaban) Phase 3 COMPASS Long-Term Open Label Extension (LTOLE) study and the XARELTO® in Combination with Acetylsalicylic Acid (XATOA) registry have been published in the European Society of Cardiology’s (ESC) European Heart Journal, Cardiovascular Pharmacotherapy. Additionally, the XATOA registry was presented at the American Congress of Cardiology’s 71st Annual Scientific Session (ACC.22). These studies provide further evidence supporting the role of dual pathway inhibition (DPI) with the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 100 mg...
Source: Johnson and Johnson - May 23, 2022 Category: Pharmaceuticals Source Type: news
Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions
RARITAN, N.J., April 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs. Data from the two analyses demonstrate the role that the XARELTO® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and ...
Source: Johnson and Johnson - April 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Janssen Initiative Aims to Advance Equitable Care and Address Hidden Threat of Amputation Related to Peripheral Artery Disease (PAD)
TITUSVILLE, N.J., March 31, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the launch of Save Legs. Change Lives.™ Spot Peripheral Artery Disease Now, a multi-year initiative aimed at creating urgency and action to address the hidden threat of peripheral artery disease (PAD)-related amputation, with an initial focus on reaching Black Americans, who are more than twice as likely to be impacted by PAD.1 Janssen has joined forces with leading professional associations, healthcare systems and community organizations to advance equitable care for individuals and communities placed at an...
Source: Johnson and Johnson - March 31, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
New ERLEADA ® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
SAN FRANCISCO, Feb. 14, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new real-world evidence data showing the initiation of ERLEADA® (apalutamide) results in high rates of rapid and deep prostate-specific antigen (PSA) response among patients with metastatic castration-sensitive prostate cancer (mCSPC). In a separate post-hoc analysis of the registrational Phase 3 SPARTAN and TITAN studies, rapid and deep PSA responses with ERLEADA® were associated with improvement in patient-reported outcomes (PROs) related to quality of life, physical wellbeing, pain, and fatigue intensity. The...
Source: Johnson and Johnson - February 14, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
